- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03941249
Blod Biomarkers for Stroke
Blood Biomarkers of Metabolic Processes (Metabolomics) and Brain Derived Proteins in Stroke Patients.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Approximately 12,000 Danes suffer a stroke each year with major consequences for those affected, their relatives and society in general. Rapid diagnosis and treatment mean less brain damage and thus less risk of late sequelae. A marker in the blood that is specific for stroke could result in faster diagnose and thereby treatment. Until now, no such marker has been found, but measurement of the so-called metabolomics and different fragments of brain proteins like Tau has shown promising results. Currently, metabolomics has only been studied in two other projects in stroke patients, and the results were not complete and a subtype of Tau (Tau-C) has been shown to be related to brain damage after ice hockey, but this is not studied in stroke patients, so there is a need for more studies.
In this project different fragments of brain proteins and the so-called metabolomics in the blood, which are small residues from the biological processes that take place in the body, such as fat and sugar incineration, will be studied.
The project is based on blood samples from a biobank that has been established in connection with previous projects in the Stroke Unit, Neurological Clinic, Rigshospitalet, Glostrup. All subjects have given written consent to give blood for future research.
Fifty microliters of blood from each participant will be analyzed by so-called mass spectroscopy, a well-researched method and performed in a recognized laboratory using known libraries and databases of metabolites for the determination and ongoing quality control. In addition, 250 microliters of serum will be analyzed by Elisa to detect brain proteins like Tau and Brevican.
The metabolomic profile and the brain proteins is compared to the information we have about the participants, namely:
- If they had ischemic or hemorrhagic stroke or if it is a healthy control person
- The extent of brain damage; partly measured by the brain scan and partly from the patient's symptoms
- The cause of the stroke
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Glostrup, Dinamarca, 2600
- Department of clinical stroke research, department of neurology, Glostrup Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Clinical stroke
Exclusion Criteria:
- Glasgow Coma Scale (GCS) < 15
- Non communicating patients e.g. aphasia (incompetent patients)
- Unable to cooperate to the physical examinations
- Pregnancy or nursing mothers
- If the investigators find the study participant unfit to conduct the investigations
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Transversal
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Ischemic or hemorrhagic stroke
Periodo de tiempo: Within 7 days
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We hope to find a method to differentiate between ischemic and hemorrhagic stroke.
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Within 7 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The extend of the brain damage
Periodo de tiempo: Within 7 days
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The relation between the biomarkers and brain damage measured by MRI.
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Within 7 days
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The extend of the physical damage
Periodo de tiempo: Within 7 days
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The relation between the biomarkers and brain damage measured by NIHSS.
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Within 7 days
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Etiology of stroke
Periodo de tiempo: Within 7 days
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The relation between the biomarkers and stroke etiology measured by the TOAST criteria.
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Within 7 days
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Stroke patient or healthy subject
Periodo de tiempo: Within 7 days
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The relation between the biomarkers and healthy subjects.
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Within 7 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Helle K Iversen, MD, DMSc, Department of clinical stroke research, Neurological department, Rigshospitalet, Glostrup
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-15021321
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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